It is well known in the art that the dose required of certain drugs to achieve and maintain therapeutic and safe levels varies significantly from patient to patient. Because overdosing of such drugs can cause a myriad of severe side effects including nausea, vomiting, convulsions, ventricular arrhythmias, seizures and cardiorespiratory arrest, the maximum effective dose to be administered is ordinarily determined on an individualized basis. Theophylline, a drug used primarily as a bronchodilator, is typical of such individualized medications.
The present method for individualizing theophylline is by titration. During titration, the patient is given an initial dose of theophylline which, dependent upon serum theophylline measurement, is adjusted either upwardly or downwardly. Subsequent doses of theophylline are then accordingly increased or decreased until the maximum therapeutic dose is achieved. Unfortunately, each adjustment of the dose level during the titration cycle requires the patient to purchase a separate and distinct potency capsule since conventional capsules can only deliver a single predetermined theophylline dose. The cost for titrating theophylline in conventional capsule form can therefore become prohibitive, especially considering the fact that capsules of theophylline are ordinarily sold only in large quantities having a uniform potency.
An additional problem with the conventional capsules used to titrate theophylline is that oral administration of the drug by sprinkling fails to deliver the entire dose carried by the capsule. Regardless of the capsule orientation, removal of either end of the conventional capsule results in a significant quantity of the drug medium escaping over the edges of the capsule housing. Consequently, it is difficult to ascertain the exact dosage which is ultimately administered to the patient. Moreover, a patient may be tempted to administer a second dose of theophylline to compensate for the inadequate delivery of the first dose. Sprinkling theophylline or other individualized drugs from conventional capsules therefore poses a serious health risk to the patient, especially considering the severe side effects associated with overdose of such medications.